scholarly journals Real-time continuous glucose monitoring versus self-monitoring of blood glucose in adults with insulin-treated type 2 diabetes: a protocol for a randomised controlled single-centre trial

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e040648
Author(s):  
Nanna Lind ◽  
Dorte Lindqvist Hansen ◽  
Signe Sætre Rasmussen ◽  
Kirsten Nørgaard

IntroductionMedical treatment options for type 2 diabetes (T2D) have increased over the last decade and enhance the possibility of individualised treatment strategies where insulin is still one of them. In spite of the advancements in treatment options, less than one-third of the population with T2D obtain their optimal glycaemic goal. In persons with type 1 diabetes, continuous glucose monitoring (CGM) has shown to be the most important driver for improvement in glycaemic control, even more than insulin-pump therapy. The use of technology in T2D has only been investigated in few studies.The overall objective of the research study is to examine the effectiveness of the use of CGM versus self-monitoring of blood glucose (SMBG) in persons with insulin-treated T2D on glycaemic variables and patient-reported outcomes on treatment satisfaction, health behaviour and well-being. The independent effect of peer support will also be studied.Methods and analysisThe study is a single centre, prospective, randomised, open-labelled, three-armed study with the randomisation 2:1:2 in group A with CGM, group B with CGM and peer support, and group C as a control group with SMBG. The participants receive a training course unique for the allocation group. The study runs for 12 months and includes 100 adult participants with insulin-treated T2D, treated at the outpatient clinic at Steno Diabetes Center Copenhagen. Primary outcome is difference in change in time in range. Recruitment begins in August 2020 and ends in July 2021. Final 12-month follow-up is anticipated to be in August 2022.Ethics and disseminationThe study will be carried out in accordance with the Helsinki Declaration and is approved by the Scientific Ethics Committee of the Capital Region (H-20000843). Data collection and handling will be performed in accordance with the General Data Protection Regulation and is approved by the Danish Data Protection Agency (J-2020-100). Dissemination will be in international peer-reviewed journals, conferences and a plain-language summary for participants.Trial registration numberClinicalTrials.gov Registry (NCT04331444).Protocol versionV.3, 11 December 2020.

Diabetes ◽  
2018 ◽  
Vol 67 (Supplement 1) ◽  
pp. 913-P
Author(s):  
YUYA TAKANO ◽  
YULIA NAMIKI ◽  
HIROKO HIIRAGI ◽  
TAKU YAMADA ◽  
HIROTO SASAKI ◽  
...  

2020 ◽  
Vol 8 (1) ◽  
pp. e001115 ◽  
Author(s):  
Eri Wada ◽  
Takeshi Onoue ◽  
Tomoko Kobayashi ◽  
Tomoko Handa ◽  
Ayaka Hayase ◽  
...  

IntroductionThe present study aimed to evaluate the effects of flash glucose monitoring (FGM) and conventional self-monitoring of blood glucose (SMBG) on glycemic control in patients with non-insulin-treated type 2 diabetes.Research design and methodsIn this 24-week, multicenter, open-label, randomized (1:1), parallel-group study, patients with non-insulin-treated type 2 diabetes at five hospitals in Japan were randomly assigned to the FGM (n=49) or SMBG (n=51) groups and were provided each device for 12 weeks. The primary outcome was change in glycated hemoglobin (HbA1c) level, and was compared using analysis of covariance model that included baseline values and group as covariates.ResultsForty-eight participants in the FGM group and 45 in the SMBG group completed the study. The mean HbA1c levels were 7.83% (62.1 mmol/mol) in the FGM group and 7.84% (62.2 mmol/mol) in the SMBG group at baseline, and the values were reduced in both FGM (−0.43% (−4.7 mmol/mol), p<0.001) and SMBG groups (−0.30% (−3.3 mmol/mol), p=0.001) at 12 weeks. On the other hand, HbA1c was significantly decreased from baseline values in the FGM group, but not in the SMBG group at 24 weeks (FGM: −0.46% (−5.0 mmol/mol), p<0.001; SMBG: −0.17% (−1.8 mmol/mol), p=0.124); a significant between-group difference was also observed (difference −0.29% (−3.2 mmol/mol), p=0.022). Diabetes Treatment Satisfaction Questionnaire score was significantly improved, and the mean glucose levels, SD of glucose, mean amplitude of glycemic excursions and time in hyperglycemia were significantly decreased in the FGM group compared with the SMBG group.ConclusionsGlycemic control was better with FGM than with SMBG after cessation of glucose monitoring in patients with non-insulin-treated type 2 diabetes.Trial registration numberUMIN000026452, jRCTs041180082.


Diabetes ◽  
2018 ◽  
Vol 67 (Supplement 1) ◽  
pp. 1664-P
Author(s):  
MINORI SHINODA ◽  
TADASHI YAMAKAWA ◽  
RIKA SAKAMOTO ◽  
JUN SUZUKI ◽  
KENICHIRO TAKAHASHI ◽  
...  

2012 ◽  
Vol 08 (01) ◽  
pp. 22 ◽  
Author(s):  
M Susan Walker ◽  
Stephanie J Fonda ◽  
Sara Salkind ◽  
Robert A Vigersky ◽  
◽  
...  

Previous research has shown that realtime continuous glucose monitoring (RT-CGM) is a useful clinical and lifestyle aid for people with type 1 diabetes. However, its usefulness and efficacy for people with type 2 diabetes is less known and potentially controversial, given the continuing controversy over the efficacy of self-monitoring of blood glucose (SMBG) in this cohort. This article reviews theextantliterature on RT-CGM for people with type 2 diabetes, and enumerates several of the advantages and disadvantages of this technology from the perspective of providers and patients. Even patients with type 2 diabetes who are not using insulin and/or are relatively well controlled on oral medications have been shown to spend a significant amount of time each day in hyperglycemia. Additional tools beyond SMBG are necessary to enable providers and patients to clearly grasp and manage the frequency and amplitude of glucose excursions in people with type 2 diabetes who are not on insulin. While SMBG is useful for measuring blood glucose levels, patients do not regularly check and SMBG does not enable many to adequately manage blood glucose levels or capture marked and sustained hyperglycemic excursions. RT-CGM systems, valuable diabetes management tools for people with type 1 diabetes or insulin-treated type 2 diabetes, have recently been used in type 2 diabetes patients. Theextantstudies, although few, have demonstrated that the use of RT-CGM has empowered people with type 2 diabetes to improve their glycemic control by making and sustaining healthy lifestyle choices.


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